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The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

• Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• Post-traumatic osteoarthritis,
• Fractures.
• Rheumatoid arthritis.
  The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
• . Multifragmental comminuted fractures of the humeral head.
• 3- and 4-Fragment-fractures of the proximal humerus,
• Head-splitting fractures.
• Dislocated head-splitting fractures,
• . Humeral head depression with more than 40% of joint surface depressed,
• Interlocking chronic dislocation with deep HILL-SACHS lesion,
• . Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening),
• Posttraumatic humeral head necrosis,
• . Omarthrosis.
  AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty to treat a patient in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary cases.
  The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
• Rotator cuff tear arthropathy,
• Chronic trauma shoulder,
• Decentering of the humeral head after implantation of a humeral head prosthesis.
  Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
  AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
  In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:
• . From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
• From Hemi Shoulder Arthroplasty to Hemi CTA . Shoulder Arthroplasty
• From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
• . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
• From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
  The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
  The device is intended for adults.
  The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared implantcast shoulder components to make a complete prosthesis.

This document describes the AGILON XO Shoulder System, a Class II medical device. The information provided outlines the regulatory submission, specifically a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device.

However, the provided text does not contain the information requested regarding the acceptance criteria and a study proving the device meets those criteria, specifically concerning advanced AI/algorithm-based performance. The context of the request (acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) is typical for the clinical validation of AI/ML-driven medical devices.

The document instead describes performance testing related to the mechanical and physical properties of the shoulder implant components, not the performance of an AI/ML algorithm.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The "Performance Testing" section explicitly mentions:

• . Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
• . Range of Motion (ROM) Evaluation

These are engineering/mechanical tests to characterize the physical device, not an assessment of an AI algorithm's diagnostic or predictive capabilities.

To answer your prompt, I would need a document that discusses the performance of an AI/ML component of a medical device, including details about its clinical validation study design and results.

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